Manufacturer
Innovasis, Inc.Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
Country / Region:United States (US)Submission type:Traditional
Product code OLO· 21 CFR 882.4560
Product code
OLO
21 CFR 882.4560
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251073
- Device name
- Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments)
- Company
- Innovasis, Inc.
- Country / Region
- United States(US)
- Product code
- OLO
- Device class
- Class 2
- Regulation number
- 21 CFR 882.4560
- Date received
- 2025-04-08
- Decision date
- 2025-07-23
- Submission type
- Traditional
- Technology type
- Image Guided Surgery(AI inferred)
- Clinical applications
- Spine SurgeryNavigation System
- Primary application
- Spine Surgery
- Classification source
- AI classified
Indications for Use
The Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis pedicle screws during non-cervical spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients. These instruments are designed for use with the Globus ExcelsiusGPS System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Intended Use
The Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis pedicle screws during non-cervical spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures for skeletally mature patients. These instruments are designed for use with the Globus ExcelsiusGPS System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Device Description
The Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) are non-sterile, reusable instruments including taps and drivers that can be operated manually. These instruments are intended to be used with the Globus Medical ExcelsiusGPS® Robotic Navigation Platform to aid in implantation of the Innovasis pedicle screw system (Vector Pedicle Screw System and Excella Spinal System) implants. The instruments are manufactured from medical grade stainless steels and plastic.
Summary parsed at:2026-06-19 05:22:11 UTC
Predicate devices
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Innovasis Navigation Instruments
K251073 references 4 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251073 as a predicate
